Supreme Court Could Hit FDA Regulation: FDLI
A lengthy Food & Drug Law Institute (FDLI) analysis shows how two fisheries cases before the Supreme Court could lead to major changes in the regulatory landscape for FDA and other federal agencies. The report says the high court appears poised to at least significantly modify, if not eliminate, the so-called Chevron doctrine that has been used to grant broad authority to federal agencies to interpret the laws they administer.
The report concludes that if the court’s decision on the two fisheries cases that challenge two National Marine Fisheries Service requirements weakens Chevron deference, “a flood of challenges to FDA’s administrative decisions may ensue.”
The analysis reviews the two-step Chevron test the Supreme Court enunciated in 1984. It then turns to FDA and its broad power under the Federal Food, Drug, and Cosmetic Act to develop advisory regulations that have the force of law provided they undergo notice-and-comment rulemaking. “But,” the report says, “FDA often treats certain nonbinding guidances and policy statements as having the force of law.” It quotes a book as saying FDA thus occasionally crosses a statutory or constitutional line when necessary to accomplish some valuable end. It adds that Chevron has been used to bolster FDA’s rulemaking power by requiring that courts defer to any reasonable agency interpretation of a statute that is deemed to be ambiguous.
The post reviews comments from several Supreme Court justices that appear to signal a recognition that the Chevron deference principle needs to be revised or eliminated. It says that when oral arguments were held 1/17 on the two fisheries cases, the justices’ questions telegraphed a likely change to the standard for agency deference.
“The questioning … confirmed that the days of Chevron, as we know it, may be numbered,” FDLI concludes. “The writing on the wall indicates that the court is poised to narrow Chevron deference significantly or replace it entirely. Regulated industry and public interest groups may benefit from a more even playing field in litigation against FDA and other agencies. In the short term, this may result in Justice (Amy Coney) Barrett’s predicted ‘flood of litigation’ challenging how agencies read and apply the law. Of course, only time will tell whether the judiciary in a post-Chevron world will more actively evaluate the scientific determinations impacting FDA’s health and safety decisions, as Justice (Elena) Kagan seems to fear. At a minimum, however, a scaling back of Chevron deference will create more uncertainty for FDA and the companies it regulates.”
FDLI also suggests that without the litigation advantage of Chevron deference, agencies may become more responsive to challenges to their interpretations. Thus, regulated industry may find even greater benefit from proactive advocacy before initiating litigation against an agency.